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Field-testing

Field-testing

Field-testing process overview

The major steps of the field-testing process are:

  1. Identify the geographic location for the testing: Manufacturer and implementing partner, with support from WHO PQS and possibly WHO and UNICEF regional offices agree on a country or countries for the field test.
  2. Drafting and approval of the field-test protocol: Manufacturer and implementing partner work with ministry of health in the selected location(s) to prepare the protocol based on guidance and resource documents provided by WHO IMD-PQS. Testing sites are identified in this process.
  3. Peer review model field-test protocol: WHO IMD-PQS arranges review by a technical specialist(s) and the IMD-PQS Working Group. Once this review is complete the protocol will be submitted to the IMD-PQS Secretariat for approval.
  4. Organize and carry out field-test: The IMD-PQS Secretariat will liaise with the manufacturer,  implementing partner and ministry of health UNICEF and/or WHO regional offices and consultants to secure the relevant authorizations and ethical clearances for the field test and identify the relevant organizations to help carry out the testing. Testing is carried out according to the approved protocol.
  5. Test and report results: Implementing partners and field counterparts conduct the test and prepare a test report, to be provided to the IMD-PQS Secretariat for peer-review within one month of receiving final data. 

    Complete details of the end-to-end field-testing process are available in the Generic guide for the field evaluation of new technologies for WHO PQS prequalification (GENERIC/GUIDE 1.1).

Guides and resources

Manufacturers who are required to field-test their products are encouraged to review the following guides and resources relating to the field-testing process, correct testing methodologies, field evaluation protocol development and test report evaluations.

Field test process & planning

Generic guide for the field evaluation of new technologies for WHO PQS prequalification GENERIC/GUIDE 1.1: Part 2 guides manufacturers on how to begin and properly plan for a field test, including assembling a team and establishing research objectives.. Part 3 provides a detailed outline of the end-to-end field evaluation process, including steps and roles and responsibilities of the different stakeholders.

Field-testing methodologies

Standard operating procedure 012: How to field test a PQS product (1 April 2020): Clause 5 of this SOP introduces two generic methods that can be used to field-test PQS products: field surveys and real-time instrumentation. The strengths and weaknesses of each method are described alongside a decision-tree to identify the most appropriate methodology.

Developing a field evaluation protocol

Generic guide for the field evaluation of new technologies for WHO PQS prequalification GENERIC/GUIDE 1.1: Part 4 of the aforemention generic guide provides a template to develop the field evaluation protocol for each field test along with instructions and guidance for completing each section of the template. The guidance also covers timelines and budgeting.

Evaluating the test reports

Generic field evaluation checklist for PQS reviewers: This checklist is intended only to assist reviewers and would not form part of a field evaluation. It can be used for reviewing a field evaluation proposal review and for final report review.

Manufacturers must submit a completed evaluation protocol for review via upload to the relevant product prequalification application on the WHO ePQS platform.